BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    SeraQuest HSV Type 2 Specific IgG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Z-CHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-513

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WALLSTENT RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·April 19, 2023

    ADVANCE

    FDA Adverse Event
    Injury ·MEDTRONIC, INC·Product code DXE·September 9, 2019

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 7, 2013

    SYNCHRON CX5 DELTA CLINICAL ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 24, 2011

    LLD #2

    FDA Adverse Event
    Malfunction ·SPECTRANETICS CORPORATION·Product code MFA·September 8, 2008

    CRIT-LINE BLOOD CHAMBER

    FDA Adverse Event
    Malfunction ·CONCORD MANUFACTURING·Product code KOC·July 21, 2018

    WALLSTENT? RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024